Waverunner
Senior Member
- Messages
- 1,079
Only a very small study but still very interesting. This treatment seems to be very cost effective and has the potential to even cure patients from C. difficile infection and colitis. The only problem I see is, that regulation prevents progress in this field. Moreover there are no incentives for big pharma companies to offer this kind of treatment, because it is so cost-effective. So who pays for the trials? How long do we have to wait, till it gets approved? 5 years? 10 years?
http://www.sciencedaily.com/releases/2013/04/130405112859.htm
Apr. 4, 2013 — A Spectrum Health clinical trial has found that fecal microbial transplantation (FMT) has resulted in the improvement or absence of symptoms in most pediatric patients with active ulcerative colitis.
The phase I clinical trial of the procedure was conducted by members of the Pediatric Specialty Department of the Spectrum Health Medical Group at Helen DeVos Children's Hospital, the first in the country to study FMT in children...
The study results have been published online by the Journal of Pediatric Gastroenterology & Nutrition and will be featured in the June print edition.
"We believe that the procedure may restore 'abnormal' bacteria to 'normal' in patients with ulcerative colitis. Our short-term study looked at the safety and tolerability of FMT for these patients."
...
Dr. Kunde explained that this single-center pilot study enrolled 10 children and young adults, ages 7-20 years, with mild to moderate ulcerative colitis...
Clinical response was evaluated with the Pediatric Ulcerative Colitis Activity Index (PUCAI) score which measures disease activity of ulcerative colitis. Clinical response to FMT was defined as decrease in the PUCAI score by 15 points. These scores were collected at baseline and weekly for four weeks after transplantation.
Results showed that, 78 percent subjects achieved clinical response within one week while 67 percent subjects maintained clinical response at one month after FMT. Thirty-three percent subjects did not show any symptoms of ulcerative colitis after FMT. Patient's clinical disease activity (PUCAI score) significantly improved after FMT compared to the baseline. No serious adverse events were noted. One of the 10 subjects could not hold the enema.
"Patients often face a tough choice between various medications that have significant side effects. Allowing the disease to progress can lead to surgical removal of their colon," said Dr. Kunde. "Our study showed that fecal enemas were feasible and well-tolerated by children with ulcerative colitis. Adverse events were mild to moderate, acceptable, self-limited, and manageable by patients."
Studies with a larger sample size and longer follow-up period are needed to determine the true efficacy of FMT in patients with ulcerative colitis, however this trial suggests that the unique biologic is a potentially effective treatment, said Dr. Kunde.
...
"This study opens the doors for an innovative, inexpensive and natural alternative to improve outcomes of this debilitating disease with billions of dollars in health care cost," said Dr. Kunde. "However, we are still in very early stages of this field and need more evidence in terms of scientifically robust multicenter clinical trials before we can offer this to patients on clinical basis. Caution must be taken that FMT should be offered by centers that follow regulatory guidelines around this new therapy and have facilities and resources available to perform the procedure."
http://www.sciencedaily.com/releases/2013/04/130405112859.htm
Apr. 4, 2013 — A Spectrum Health clinical trial has found that fecal microbial transplantation (FMT) has resulted in the improvement or absence of symptoms in most pediatric patients with active ulcerative colitis.
The phase I clinical trial of the procedure was conducted by members of the Pediatric Specialty Department of the Spectrum Health Medical Group at Helen DeVos Children's Hospital, the first in the country to study FMT in children...
The study results have been published online by the Journal of Pediatric Gastroenterology & Nutrition and will be featured in the June print edition.
"We believe that the procedure may restore 'abnormal' bacteria to 'normal' in patients with ulcerative colitis. Our short-term study looked at the safety and tolerability of FMT for these patients."
...
Dr. Kunde explained that this single-center pilot study enrolled 10 children and young adults, ages 7-20 years, with mild to moderate ulcerative colitis...
Clinical response was evaluated with the Pediatric Ulcerative Colitis Activity Index (PUCAI) score which measures disease activity of ulcerative colitis. Clinical response to FMT was defined as decrease in the PUCAI score by 15 points. These scores were collected at baseline and weekly for four weeks after transplantation.
Results showed that, 78 percent subjects achieved clinical response within one week while 67 percent subjects maintained clinical response at one month after FMT. Thirty-three percent subjects did not show any symptoms of ulcerative colitis after FMT. Patient's clinical disease activity (PUCAI score) significantly improved after FMT compared to the baseline. No serious adverse events were noted. One of the 10 subjects could not hold the enema.
"Patients often face a tough choice between various medications that have significant side effects. Allowing the disease to progress can lead to surgical removal of their colon," said Dr. Kunde. "Our study showed that fecal enemas were feasible and well-tolerated by children with ulcerative colitis. Adverse events were mild to moderate, acceptable, self-limited, and manageable by patients."
Studies with a larger sample size and longer follow-up period are needed to determine the true efficacy of FMT in patients with ulcerative colitis, however this trial suggests that the unique biologic is a potentially effective treatment, said Dr. Kunde.
...
"This study opens the doors for an innovative, inexpensive and natural alternative to improve outcomes of this debilitating disease with billions of dollars in health care cost," said Dr. Kunde. "However, we are still in very early stages of this field and need more evidence in terms of scientifically robust multicenter clinical trials before we can offer this to patients on clinical basis. Caution must be taken that FMT should be offered by centers that follow regulatory guidelines around this new therapy and have facilities and resources available to perform the procedure."
